With EU Support a New Twinning Project in the Area of Medicines and Medical Devices is Launched

The formal opening ceremony organised on 9 March 2017 by the Delegation of the European Union to the Republic of Moldova, the Medicines and Medical Devices Agency of the Republic of Moldova, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland marked the official start of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” which will strive to improve the quality of the medicines, medical devices and pharmaceutical activity in the Republic of Moldova.

The overall objective of this EU-funded Twinning Project is full and correct implementation of the EU acquis in the area of medicinal products and medical devices and preparation of the Medicines and Medical Devices Agency of the Republic of Moldova (“MMDA“) for joining the EU regulatory agencies network as an equal partner.

The EU Ambassador to the Republic of Moldova H. E. Mr. Pirkka Tapiola at the opening speech stated that “the successful implementation of this project will help develop capacities of the health agency, which will match the level of peer institutions in the EU Member States. In this way the EU is providing assistance for ensuring continuous access to medicines of a good quality.”

H. E. Mr. Rimantas Latakas, the Ambassador of the Republic of Lithuania to the Republic of Moldova emphasized that “This project shall harmonize the competences of the Agency of Medicines and Medicinal Devices at the same level with peer institutions from Member States and shall allow the patients to benefit from safe, high quality and efficient medicinal products and medical devices”.

“This project shall bring us closer, Poland and Lithuania are neighbors within EU and due to previous reforms we advanced in these areas and are delighted to share our experience with you. Moreover, such projects create a sense of proximity, since the Republic of Moldova is already a country associated to EU and you have the right to benefit from our assistance“, claimed the Ambassador of the Republic Poland to the Republic of Moldova H.E. Mr. Arthur Michalski.

The Vice-Minister of Health of the Republic of Lithuania Dr. Kristina Garuolienė emphasized that this Project will strengthen the existing cooperation between Lithuania and Moldova in the field of health and that Lithuania will continue to support Moldova’s goals to improve and strengthen the health of the population of Moldova.

Dr. Agnes Saint-Raymond noted that “the European Medicines Agency (EMA) welcomes and supports this project, which builds capacity and contributes to delivering high-quality medicines to patients in Europe.”

Mr. Gintautas Barcys, the Director of the Lithuanian State Mecines Control Agency added that “This EU-funded Twinning Project will strive on strengthening of the capacities of the Medicines and Medical Devices Agency of the Republic of Moldova and enable it to collaborate with other EU agencies in area of the medicinal products and medical devices”.

„This Project proves that firm neighbourhood partnership which exist between Poland and Lithuania may be beneficial not only for citizens of this respective countries, but as well for states outside the EU with great impact on their regulatory system, legal framework and future better access to safe medicines and medical devices“, admited the President of the Office for Registration of Medicinal products, Medical Devices and Biocidal Products Dr. Grzegorz Cessak.

The EU-funded Project will be implemented over a 24 months period. The main purpose this EU-funded project worth 1 100 000 EUR is to strengthen the functioning of the MMDA with regards to medicinal products manufacturing, marketing, pharmacovigilance, distribution and pricing and medical devices in scope of market supervision, vigilance and registration as well as to clinical trials and pharmaceutical activity. The completion of this EU-funded Project should deliver the MMDA with capacities at the same level as peer institutions in the EU Member States and should allow patients to benefit from safer, better quality and more effective medicinal products and medical devices.

The EU-funded Twinning project will be implemented by the EU MS partners – Ministry of Health (Republic of Lithuania), State Medicines Control Agency under the Ministry of Health (Republic of Lithuania), Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Republic of Poland) and Central Project Management Agency (Republic of Lithuania) in cooperation with the partner institution in the Beneficiary Country – Medicines and Medical Devices Agency of the Republic of Moldova.